This website is for Private Investors* only

*A Private Investor is a recipient of the information who meets all of the conditions set out below, the recipient:

Obtains access to the information in a personal capacity;

Is not required to be regulated or supervised by a body concerned with the regulation or supervision of investment or financial services;

Is not currently registered or qualified as a professional securities trader or investment adviser with any national or state exchange, regulatory authority, professional association or recognised professional body;

Does not currently act in any capacity as an investment adviser, whether or not they have at some time been qualified to do so;

Uses the information solely in relation to the management of their personal funds and not as a trader to the public or for the investment of corporate funds;

Does not distribute, republish or otherwise provide any information or derived works to any third party in any manner or use or process information or derived works for any commercial purposes.

Banking

Energy Producers

Engineering

Mining

Economy

Market Report

Companies

Currencies

GSK's ViiV seeks approval for new one-tablet HIV-1 treatment

ViiV Healthcare - the HIV specialist majority-owned by GlaxoSmithKline, alongside minority shareholders Pfizer and Shionogi - announced the submission of a marketing authorisation application to the European Medicines Agency on Friday, for a single-tablet, two-drug regimen of dolutegravir and lamivudine for the treatment of the HIV-1 infection.

1,533.80

14:00 22/02/19

7,194.46

14:00 22/02/19

3,999.16

14:00 22/02/19

3,945.28

14:00 22/02/19

The company said the submission was based on the global GEMINI 1 and 2 studies, which included more than 1400 HIV-1 infected adults with baseline viral loads up to 500,000 c/mL.

It presented the results of those studies at the 2018 International AIDS Society meeting in July.

“We continue to demonstrate our commitment as a company to developing new medicines for people living with HIV and providing options for reducing the number of medicines they will have to take as part of life-long treatment,” said ViiV Healthcare chief executive officer Deborah Waterhouse.

“This regulatory submission, if approved, will make available a two-drug regimen option with dolutegravir and lamivudine instead of the traditional three-drug regimen and is an important step in the evolution of HIV treatment.”

John C Pottage Jr, the company’s chief scientific and medical officer, said that ViiV wanted to make HIV a smaller part of people's lives throughout their treatment journey, and was “committed” to challenging the status quo with innovations that were based on our belief that no patient should take more medicines than they needed.

“If approved, a single-tablet, 2-drug regimen of dolutegravir and lamivudine would mark a new era in HIV treatment for people newly diagnosed with HIV,” Dr Pottage explained.

ViiV said that s new drug application to the US FDA was also planned for the single tablet regimen for October, using a priority review voucher.

Other global regulatory submissions of dolutegravir and lamivudine as a single-tablet, two-drug regimen for HIV-1 therapy were also anticipated in the coming months.